NCT02509455

Brief Summary

To investigate whether an extended version of Valedo®Motion (termed Sensoro for brand management purposes), has the same trunk sway measures similar normal reference values of SwayStar. Offline data analysis of data obtained from Sensoro will be compared to data obtained by SwayStar, a highly accurate and widely accepted system for measuring balance control.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress96%
Jun 2015Dec 2026

Study Start

First participant enrolled

June 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

11.2 years

First QC Date

July 20, 2015

Last Update Submit

July 11, 2025

Conditions

Healthy

Keywords

Balance controlBody-mounted sensorsBalance Measures

Outcome Measures

Primary Outcomes (1)

  • Trunk sway angular velocity and displacement stance and gait tasks.

    Is trunk sway angular velocity and displacement measured with SwayStar different when measured with Sensoro for a battery of stance and gait tasks

    1 year

Study Arms (2)

Normal 1

SwayStar device used 1st, Sensoro used 2nd

Normal 2

Sensoro device used 1st, SwayStar used 2nd

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy adults

You may qualify if:

  • self reported lack of balance problems (checked by the ability to stand on 1 leg, eyes closed, for at least 14 secs).

You may not qualify if:

  • orthopaedic problems
  • presence of diseases which cause balance problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lab for Exp Otoneurology, University Hospital Basel

Basel, 4056, Switzerland

RECRUITING

Study Officials

  • John HJ Allum, DSc

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John HJ Allum, DSc

CONTACT

+41612652041john.allum@usb.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2015

First Posted

July 28, 2015

Study Start

June 1, 2015

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations

CH(1)